Medication packaging and labeling system

ABSTRACT

Method for generating a label for a medication in which information about the medication is obtained and printed on the label in a hierarchical manner with more important information in a more prominent location or more prominent type relative to other less important information. The information may be divided into primary information and secondary information with the primary information being placed on the label before the secondary information. The label may be used in a container having a curved front wall, a planar rear wall, a substantially planar bottom wall and a cap engaging with the front and rear walls to seal the container. The rear wall is constructed with a device for removably received an information card containing information relating to the medication.

FIELD OF THE INVENTION

The present invention relates generally to an integrated medicationpackaging and labeling system and more specifically to a prescriptionmedication packaging and labeling system which is designed to clearlyprovide information about the medication in order to avoid misuse of themedication.

The present invention also relates independently to a label forprescription medication, a method for generating a label forprescription medication, a container for prescription medication and aninformation card for prescription medication.

BACKGROUND OF THE INVENTION

Unfortunately, there are numerous instances in which prescriptionmedication is misused with harmful and often fatal results. Misuse mayinvolve a variety of different factors, such as taking the correctmedication in an improper manner, at an incorrect time schedule and/orat an incorrect time with respect to meals, as well as taking theincorrect medication resulting from similarities between the shape,size, name and/or color of different medication and the bottles orcontainers in which different medications are dispensed.

Medication misuse often involves people, e.g., elderly people, who havedifficulty reading and/or understanding the directions for using aparticular medication. For example, it is known that Cardizem CD™, aprescription medication for blood pressure control, must be swallowedwhole in order to be effective. This fact is indicated on the label thataccompanies dispensation of the medication. However, elderly people mayexperience problems swallowing a large capsule and therefore mightresort to breaking the capsule into smaller parts or chewing thecapsule. This negates the pharmacological effects of the medication sothat even though the patient is taking the medication, the desiredcontrol of the blood pressure is not being obtained in view of themisuse of the medication.

In the U.S., almost as much money is spent addressing the complicationscaused by home medication errors as is spent purchasing all themedications dispensed. Three years ago, almost $76 billion a year wasspent purchasing medications in the U.S. while another $76 billion wasspent treating medication errors including, but not limited to, errorscaused by complications experienced by individuals as a result ofmisunderstandings in taking their medications. The cost of homemedication increases ($180 billion+) when the costs to an employer forabsenteeism, on-the-job injuries, etc. are included. Home medicationerrors are a national public health issue that is harming patients andthe health care system, as well as the productivity of the U.S.

When a person is non-adherent, i.e., does not follow the properinstructions for taking medication, the cost of the treatment increasesfor both the consumer and the health care insurance provider. The wiseuse of prescription drugs can save lives. Prescription drugs should notbe causing such high rates of medical complications and deaths as aresult of people not being adequately informed. Home medication errorsmade by patients are linked to hundreds of thousands of deaths a yearand cost this country nearly $180 billion in extra medical treatments.

In an attempt to avoid such misuse, accurate and detailed information istypically provided on labels affixed by a pharmacist to containers ofprescription medication specifying the exact manner in which theprescription medication should be used.

Each pharmacy typically has its own label design that may be tailored toits specific needs as well as designed to be in compliance with anyregulatory or statutory requirements. The label provides theprescription user with instructions and other necessary information toavoid misunderstandings that could lead to misuse of the medication. Theinformation typically contained on the label includes the name, addressand telephone number of the pharmacy, a prescription number, a date onwhich the prescription is prepared, an expiration date of the prescribedmedication, the patient's name and address, the dosage and time schedule(e.g., 2 tablets every four hours), the prescribing doctor's name, thenumber of permissible refills, if any, the name of the medication, thenumber of capsules or tablets in the bottle, the weight of each capsuleor tablet and indications as to whether the medication should be takenwith meals, before meals, after meals, with liquids, not in combinationwith certain products, refrigerated, and the like.

There is no specific order in which the information provided on thelabel must be displayed. As such, each pharmacy's label is different.This causes inconveniences when one person has multiple prescriptions,each filled at a different pharmacy. Although the patient might befamiliar with a label from one pharmacy and know where to look on thatlabel to find information about taking the medication, he or she wouldhave to search for the same information on a label from a differentpharmacy.

In addition, when generating forms for prescription labels, pharmaciesoften do not prioritize the information, i.e., create an order in whichthe information is to be printed, for example, based on relevancy.

Thus, in a significant number of current prescription labels, there isno hierarchy of importance of the information contained thereon. Rather,it is often the case that the information about the pharmacy, includingits logo, if any, is the most prominently displayed information.

Another inconvenience for patients taking medication relates to warningstickers which are applied to the containers at the pharmacy. Suchwarning stickers generally have a standard form and some warningstickers are bright orange or red with black printing. When placed onthe containers, it is difficult to read the warnings since the blacktype does not stand out against the bright colors of the warningstickers, i.e., there is not sufficient contrast. Moreover, the red andorange warning stickers do not stand out against amber containers whichare used in some pharmacies.

Another possible inconvenience arises when the stickers are affixed tothe container and inadvertently cover up a significant amount of text onthe label. This creates a problem for patients to read the informationprinted on the labels. In addition, the warning sticker also becomesdifficult to read.

From the warning stickers to the placement of text on the labels to thesize of the type used on the labels, there is no consistency in thelabeling of prescriptions. As such, important information regarding theuse of a medication is often overlooked since there is no indicationthat such information is important or even critical to the use of themedication. It would therefore be advantageous to provide a prescriptionlabeling system in which information is placed in the order ofimportance so that important information is placed before information oflesser importance and is therefore not susceptible to being overlooked.

Another problem with prior medication systems is that the medicationcontainers are usually cylindrical in shape such that the label iswrapped around the entire bottle. In this manner, the informationprinted on the label is difficult to read since, in order to read all ofthe information, the bottle must be held and rotated. It would beadvantageous if all of the information about the prescription on abottle were to be visible to a patient without having to rotate thebottle.

After dispensing the proper medication, most pharmacies place the filledcontainer in a paper bag with printed information about the prescriptionas well as additional information about the prescription such as theprice. The bag itself is typically branded with the pharmacy's identityand possible advertisements. The bag also may include information aboutthe fastest way to refill the medication. The customer receipt andprescription information page are attached to the bag. The prescriptioninformation page is often a sheet of paper about 8.5 inches by 12inches, folded, with text on both sides. The text is small and laid outwith around 26 words per line. The prescription information page is thusoften disregarded in view of the sheer amount of text thereon and therelatively small type. Such presents a problem as the information on theprescription information page is extremely important as it describesvarious properties of the particular drug such as what it is, how to useit, side effects, precautions, drug interactions, overdose, missed doseand storage. Sometimes, this is the only form of communication thepatient has with the pharmacist.

OBJECTS AND SUMMARY OF THE INVENTION

It is an object of the present invention to provide a new and improvedintegrated medication packaging and labeling system and method.

It is another object of the present invention to provide a new andimproved prescription medication packaging and labeling system andmethod which are designed to clearly provide information about themedication in order to avoid misuse of the medication.

It is yet another object of the present invention to provide a new andimproved label for prescription medication that conveys informationabout the prescription in a clear and comprehensive manner.

It is another object of the present invention to provide a new andimproved container for prescription medication.

Another object of the present invention is to provide a customizablepackaging and labeling system for pharmacies and other prescriptionmedication dispensing facilities which increases the confidence of theusers of the system by enabling them to generate prescription labelswith clearly structured information about the prescriptions utilizingboth color and graphics.

To achieve these objects and others, a method for generating a label fora prescription medication for a patient in accordance with the inventioncomprises obtaining information about the prescription including thepatient's name and home address, the name, form, purpose, dosage andexpiration date of the medication, the manner in which the medication isto be taken, the number of refills of the prescription, the quantity ofmedication to be dispensed, the prescribing doctor's name and DEAnumber, and the date the prescription is written. The information isprinted on the label in a hierarchical manner with more importantinformation in a more prominent location or more prominent type relativeto other lesser important information. An organized contrast is therebyprovided between the different types of information with a view towardcreating a clear and simple label that is easy to read and comprehend.

The information is divided into primary information and secondaryinformation, i.e., information of lesser importance than the primaryinformation. The primary information is placed on the label before thesecondary information and would be information such as the patient'sname and home address, the name, form, purpose and dosage of themedication and the manner in which the medication is to be taken. Thesecondary information is all other information. Arranging theinformation in this manner has been shown to increase patientcomprehension when taking medication. For example, Dan Morrow, apsychology professor at the University of New Hampshire, has conducted aconsiderable amount of research in this area. See Daniel G. Morrow, VonO. Leirer, Jill M. Andrassy, Elizabeth Decker Tanke, and Elizabeth A. L.Stine-Morrow, “Medication Instruction Design: Younger and Adult Schemasfor Taking Medication,” Human Factors, 38 (1996): 556-573, which isincorporated herein by reference.

Instead of printing all of the information in a non-coherent manner onthe label, the information which is printed on the label in accordancewith the invention is placed in demarcated information areas, severalsuch information areas being rectangular having an equal length andaligned with the left side of the label. Another information area may bevertically oriented alongside the rectangular information areas and isreserved for information about the dispenser of the medication, i.e.,the pharmacy.

Additional features may be provided to facilitate easy identification ofthe medication. For example, the name of the medication is preferablyplaced in the largest font size and in black ink on a shaded background.Also, an icon or pictogram of the medication may be provided next to thename of the medication. This enables illiterate people to be able toidentify their medicine by its form. In addition, the use of pictogramsenables patients to detect mistakes in the dispensing of the medication,e.g., if the form of the medication does not correspond to thepictogram. The font, the font size and/or font type of the informationin the information areas can be controlled and selected to increase thecontrast of the information and highlight the more importantinformation.

Color-coding is also used, e.g., by coloring one or more of theinformation areas, to convey information about the prescription. Suchinformation might include the identity of a particular family member towhom the medication was prescribed (when each family member is assigneda separate color by the pharmacy) or the fact that the medication ishigh-risk. In addition, color-coding may be used to differentiatebetween different families of medications. For example, all heartmedications can be colored pink.

A container for medication, to which the label described above may beaffixed, is also provided in accordance with the invention. Thecontainer comprises a curved front wall, a planar rear wall, asubstantially planar bottom wall and a cap engaging with the front andrear walls to close and seal the container. The label of the inventionmay be affixed to the front wall such that the information printed onthe label is easier to read as compared to prior art medication bottles.

The rear wall of the container includes a device for removably retainingan information card that contains information relating to themedication. The retaining device may constitute a shoulder arranged ateach lateral edge of the rear wall, each shoulder including an inwardlyfacing groove such that a slot receivable of the information card isdefined by the grooves.

Thus, the system in accordance with the invention comprises a uniquelabel, a unique medicine container and a unique information card.Together, these components serve as an interface that provides areliable and safe alternative to current systems, which often fail toconvey information in a clear and comprehensive manner.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention, together with further objects and advantages thereof, maybest be understood by reference to the following description taken inconjunction with the accompanying drawings wherein like referencenumerals identify like elements.

FIG. 1 shows a prescription label in accordance with the inventionwithout information regarding a particular prescription.

FIG. 2 shows a prescription label in accordance with the inventionincluding information about a prescription.

FIG. 3 shows various pictograms used on a label in accordance with theinvention.

FIG. 4 shows an embodiment of the invention with a self-expirationfeature.

FIG. 5 is a front view of a container in accordance with the inventionto which the label shown in FIG. 1 can be applied.

FIG. 6 is a side view of the container shown in FIG. 5.

FIG. 7 shows several containers in accordance with the invention havinglabels in accordance with the invention applied thereto.

FIG. 8 shows an information card in accordance with the inventionalongside a container in accordance with the invention.

FIG. 9 shows the magnifying lens which can be placed in connection withthe container in accordance with the invention.

FIG. 10 shows a sheet having a label section and data section forcreating labels in accordance with the invention.

FIG. 11 shows a sheet having a label section and data section created inaccordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring first to FIG. 1, a prescription label in accordance with theinvention is designated generally as 10 and includes a uniquearrangement of demarcated information areas in which specificinformation concerning the prescription is printed. The information tobe printed in each information area is selected based in part on theimportance of the information to the patient and with a view towardclearly conveying the proper use of the medication so as to avoidharmful and even potentially fatal errors in the use of the medication.

The arrangement and content of the label is designed to prevent theunfortunately all too common problem of people getting sick andsometimes dying due to mistakes such as misreading a dosage or notseeing a warning label when taking medication. Thus, the label isdesigned to make the medication user's experience less confusing. Thisis done by generally combing the ideas of information architecture withcognitive functions of older adults. The label is the result of asignificant amount of research which determined the layout ofinstructional information.

Based on the research, an intuitive label is provided in whichinformation to be presented thereon is divided into two categories,primary and secondary. The primary information reflects relativelyimportant information, exactly what the patient wants and needs to knowfirst to avoid misuse of the medication such as the name of the drug,its purpose, dosage and how to take it. The secondary informationreflects information of lesser importance, such as the expiration date,quantity, name of the doctor prescribing the medication, how to reachthe doctor, etc. The secondary information also includes the drug store,the refill number and the dispensing date. The hierarchy of theinformation, e.g., the order, position, type size, contrast, leading,alignment and choice of typefaces, is another important factor to afunctional and clear label. In combination, the order of presentation ofinformation and the manner in which the information is presented,coupled with the consumer's point of view, is crucial to the success oflabeling system in accordance with the invention in the prevention ofmisuse of medication.

To achieve this purpose, the labels 10 are partitioned into a pluralityof discrete information areas and a label dispensing machine can be usedwhich prints the partitions lines when printing the information on thelabel. In the alternative, the labels can be pre-printed with thepartition lines between the information areas. In general, the label 10is formed on a substrate having an adhesive backing layer so that whenthe backing layer is removed, the label 10 can be affixed to a containervia the adhesive layer.

A first information area 12 is arranged at the top of the label 10,extending almost entirely across the top of the label 10. Informationarea 12 is printed with the patient's full name and the patient's homeaddress below the patient's name.

Information area 14 is arranged below information area 12 and is ashaded region in which the identification or name of the medication isprinted. The identification of the medication may be the trademarkedname of the medication, if this version is prescribed, or the equivalentgeneric name if a generic is available and prescribed or dispensed.

Information area 14 also includes an icon or pictogram 14 a of themedication proximate the right edge of the information area 14. Thepresentation of the pictogram 14 a serves to distinguish generally, forexample, between capsules and tablets. By providing a pictogram 14 a ofthe medication on the label 10, errors arising from taking the wrongmedication can be prevented when two or more prescribed medications havedifferent forms. For example, if a capsule is prescribed for one illnessand a tablet for another, then the patient could view the pictogram 14 aof the medication on the label 10 and know which medication is the rightone to take. The patient would not have to consider even the name of themedication. Of course, this is not possible when the same type ofmedication is prescribed, such as two tablet-form medications.

In addition, the use of pictograms will enable patients to detectmistakes in the dispensing of the medication, e.g., if the form of themedication does not correspond to the pictogram. Possible pictograms 14a are discussed below with reference to FIG. 3.

Below information area 14 is information area 16 which contains a briefdescription of the purpose of the medication. A variety of purposes aredesignated for application by the label printing machine and may include“sleep-aid”, “blood pressure control”, “anti-biotic”, “lowerscholesterol”, “antihistamine”, “cough-cold”, “migraine”, “anti-anxiety”,“anti-psoriasis” and “anti-arrhythmic”. At the right edge of informationarea 16 is the dosage 16 a of the medication, i.e., the strength orweight of the medication (10 mg, 20 mg, 100 mg, etc.).

A large information area 18 is arranged below information area 16 andincludes the word “take” followed by instructions on the manner in whichthe medication should be taken. Precise and detailed instructions inplain language may be provided in view of the large size of informationarea 18. For example, possible instructions may be “1 to 2 tablets atbedtime as needed”, “2 tablets before meals”, “1 tablet every 12 hours”,“swallow 2 tablets every six hours” and the like. The information area18 can also include a notation of “HIGH ALERT” (as shown in the middlelabel 10 of the container shown in FIG. 7) or a warning not to take morethan a specific number of capsules or tablets per day.

The information in information areas 12, 14, 16, 18 may be consideredthe primary information in that it is the basic information needed toproperly administer or take the medication. The name of the patient forwhich the medication is prescribed is necessary to avoid the situationwhere one person takes another medication. The name of the medication isnecessary to avoid the situation where the wrong medication is taken.The purpose of the medication is necessary to clarify the condition andreason why the medication is being taken so that if the condition is nolonger present, the medication would not be required. This happens whena medication is taken as a pain reliever so that once the pain is nolonger present, the medication can be stopped. The instructions abouthow to take the medication are necessary to avoid the situation wherethe medication is taken improperly and thus may not provide its intendedand expected benefits.

Additional information is also printed on the label 10 and is consideredthe secondary information in that it is less important for correct usageof the medication than the primary information. To this end, informationarea 20 is arranged below information area 18 and includes informationabout the expiration date of the medication, the date beyond which themedication may not be effective. Information area 22 is belowinformation area 20 and includes information about the number ofpossible refills of the medication and the quantity of tablets orcapsules in the prescription. The label 10 includes the word “expires:”following by space for the expiration date, the word “refill:” followingby a space for number indicative of the number of refills available, andthe word “qty:” or “quantity” following by a space for the quantity oftablets or capsules in the prescription.

Information area 24 is below information area 22 and includesinformation about the doctor prescribing the medication, including forexample, his or her phone number and optionally the address, the datethe prescription is written and the doctor's DEA number.

Information areas 12-24 are substantially rectangular and have a commonlength. The width of the information areas 12-24 varies as shown inFIG. 1. The demarcation lines between the various information areas areusually 0.5 in weight and 30% black. However, the line 60 between theprimary information in information area 18 and the secondary informationin information area 20 is twice as thick and 1 pt in weight and 100%block. This demarcation line separates the primary information from thesecondary information.

Another information area 26 is arranged at the right of informationareas 12-24 and the print therein is vertically oriented. Informationarea 26 includes the logo of the store or pharmacy dispensing theprescription and information about the store or pharmacy including forexample, the prescription number, the phone number and optionally theaddress, and the date the prescription is dispensed.

To complete the label 10, other printed information can also be providedif desired, needed and/or required by law. For example, as shown in FIG.1, the label 10 includes an indication that warnings and druginformation is on the back of the label (information area 28) and acautionary statement that federal law prohibits transfer of the drug toany person other than the patient for whom the drug is prescribed(information area 30). The indication in information area 28 is blackprint on a color background and the particular color used is indicativeof the type of warning. This feature is discussed in greater detailbelow.

In addition to the arrangement and content of the information areas12-26, the font, type and capitalization used to print the informationis selected to optimize the conveyance of information about theprescription and its usage. Specifically, the printed information hasdifferent types with more important information printed in a larger typethan information of lesser importance. As an example, in the labelillustrated in FIG. 2, the name of the medication in information area 14has the largest font (15.5 pt) and is printed in capital letters in viewof its overriding importance. The patient's name in information area 12has the next largest font (12 pt) following by the instructions ininformation area 18 in 11 pt (the word “take” in information area 18being slightly smaller in 10 pt) and the information in informationareas 20 and 22, i.e., the expiration date, refill number and quantity,also in 11 pt (the words “expires:”, “refill:” and “qty:” being slightlysmaller in 10 pt). The purpose of the medication in information area 16is printed in 9.5 pt and the patient's address in information area 12and the doctor's information in information area 24 is printed in 8.5pt. In information area 26, the prescription number, and the phonenumber are printed in 8.5 pt while the date the prescription isdispensed is printed in 7.5 pt. The dosage information printed ininformation area 16 is printed in 8 pt. The indication in informationarea 28 is printed in 8 pt and the federal warning in information area30 is printed in 7 pt.

With respect to the font, it has been found that the Myriad Roman fontis an extremely advantageous font since it provides clear letters whenused either plain, in an italics mode or in a bold or semi-bold mode.The particular mode of the Myriad Roman font used for the informationprinted in each information area is preferably selected to optimize theconveyance of information on the label. (In the label illustrated inFIG. 2, only the federal warning in information area 30 has a differentfont, i.e., Helvetica condensed.)

In the embodiment illustrated in FIG. 2, the patient's name is printedin italics and the name of the medication, the patient's address and thedoctor's name and DEA information are printed in capitals. Bold print isused for the name of the medication in information area 14 and the phonenumber of the pharmacy and the prescription number in information area26. A semi-bold print is used for the purpose of the medication ininformation area 16, the doctor's name and the notation “DEA:” ininformation area 24 and the expiration date, refill number and quantityin information area 20. Small caps are used for the indication ininformation area 28.

In addition, the numbers relating to the instructions for taking themedication, in information area 18, may also be printed in bold type.This will serve to highlight, for example, the number of tablets and/orthe hours between taking the medication. An instruction can thereforebe, for example, “1 or 2 capsules every 4 hours as needed”. This clearlyconveys to the patient the proper administration of the medication.

As also shown in FIG. 2, all of the text (except the dosage ininformation area 16 and the pharmacy information in information area26), should preferably be left-justified and lined up.

As noted above, the indication in information area 28 is printed inblack ink on a color background. It is possible to obtain numerousdifferent colors using any commercially available color printer whichcan be adapted to print prescription labels. Possible colors used in theinvention are green, orange, blue, gray, pink and yellow and thesecolors, as well as possibly other colors, can easily be produced by mostany color printer.

The color of the information area 28 can be used to convey specificinformation designed to prevent misuse of the medication. For example,each member of a family can be assigned a different color and wheneverthat member has a prescription filled, the information area 28 will beprinted in that color. In this manner, each member will know only totake medication having his or her color. This will enable each patientto take the correct medication in a situation where two members of thesame family are taking the same medication but different doses, e.g.,one is taking Ambien 10 mg and the other is taking Ambien 50 mg. Bycolor-coding at least a portion of the label, and associating eachindividual color with a particular family, member, each family memberwill know only to take medication having his or her assigned colorthereon.

Assignment of different colors to different family members may be donewhen the family first fills a prescription at a pharmacy incorporatingthe labeling system in accordance with the invention. The family memberwould complete a form listing the family members and each would selector be assigned a color for the label. The system would prevent theselection or assignment of the same color to more than one familymember. If a patient-consumer lives alone, he or she can always choose adefault color. Instead of assigning different colors to different familymembers, it is also possible to use color-coding for morning pills andnighttime pills. This might be used by a person living alore. As such,he or she could code labels pertaining to morning pills one color andtheir evening pills another color. Alternatively, color-coding can beused universally to differentiate between different families ofmedications.

The use of a particular color on the label is a quick and easy way for apatient to identify a particular medication since color is mentallyprocessed in a short amount of time. Use of color therefore helps avoidconfusion when multiple medications are present. Instead of limiting thecolor-coded portion to information area 28, other portions of the labelscan be colored, for example, the borders or possibly information area14.

In some instances, it might be desirable to use a specific color, suchas red, on a portion of the label to identify high-risk medications.

FIG. 3 shows possible icons or pictograms 14 a of medications which canbe printed in information area 16 alongside the name of the medication.The pictograms 14 a include one for capsules which is oval and dividedin half with each half being colored differently, one for tablets whichis round and divided in half, one for suppositories having the generalshape of a suppository, one for syrup having the shape of a drop offluid and one for oblong tablets which is oval with a line in the middleand uncolored.

As noted above, by displaying a pictogram of the medication on thelabel, when multiple medications are prescribed having different forms,the pictogram provides a quick and easy way to determine the medication(assuming it is known that one medication is in one form and the othermedication is in another form). In addition, displaying a pictogram ofthe medication on the label allows the patient to detect if the medicinein the container to which the label 10 is affixed does not match thepictogram 14 a. If so, the patient will hopefully avoid taking themedication and clarify the situation as to which medication should betaken.

Referring now to FIG. 4, the label 10 in accordance with the inventioncan be provided with a self-expiration mark 62. This type of mark 62 isuseful because many medications lose their potency over time and becomeunsafe if used beyond the expiration date.

The label 10, when generated, is provided with a time-releasedexpiration mark 62, such as stripes of red color against a whitebackground, which appear on the label 10 when the medication hasexpired. While initially the label 10 has a generally white background,stripes of color will appear upon expiration of the medication notifyingthe user that the medication has expired. If the label has a big red “X”going through it, it should be clear to the patient that the medicine isno longer effective and could be dangerous.

The application of a time-release expiration mark to labels has beendeveloped by Temtec Inc. of Suffern, N.Y. which makes a product calledTempBadge. The following U.S. patents owned by Temtec are incorporatedherein by reference: U.S. Pat. Nos. 4,605,246, 5,446,705, 5,602,804,5,633,835, 5,640,742, 5,699,326, 5,715,215, 5,719,828, 5,755,175,5,785,354, 5,822,280, 5,862,101, 5,873,606, 5,930,206, 5,947,369,5,957,458, 6,086,971, 6,197,396 and 6,295,252.

Referring now to FIGS. 5-8, the label 10 described above can be appliedto any conventional containers or can be used in combination with aspecially designed container designated generally as 32. Container 32has a curved, preferably semi-circular, vertically oriented front wall34, a planar rear wall 36, and a substantially planar bottom wall 38having an edge that conforms to the curvature of the front wall 34. Acover or cap 40 engages with the front and rear walls 34,36 at an upperportion thereof to close the container 32. Cap 40 includes a tongueportion 42 to facilitate opening of the cap 38 and access to themedication in the container 32.

The container 32 in accordance with the invention thus does not have theconventional cylindrical form. Several advantages are provided by thecontainer 32 in accordance with invention. The user should feelcomfortable using the container 32 since it is similar to the existingcylindrical containers, and not entirely different as would be the caseif a container having a rectangular cross-section were to be used.

It has also been found that it is easier to read information on asemi-circle as opposed to having information printed all around acylindrical container which would require the container to be turned ina complete circle to obtain all of the information printed thereon.Turning the container creates fragmented instructions.

In addition, the rear of the container 32 is planar and includes aretaining device which enables an information card and/or magnifyinglens to be retained in a fixed position relative to the container. Theinformation card would thus be easy to read without requiring anyturning of the container 32.

Moreover, the semi-circular shape of the container 32 takes up lessspace in medicine cabinets and on kitchen counters where medication isusually stored.

The rear wall 36 of the container 32 includes at least one retainingdevice for enabling an information card 48 or magnifying lens to beretained in a fixed position relative to the container. A shoulder 44 isformed along each lateral edge of the rear wall 36 extending from thebottom of the rear wall 36 to the top of the rear wall 36 and eachshoulder 44 includes a groove or ridge 46. An information card 48(discussed below) or any other relevant material can slide in and out ofa slot 50 formed by the grooves 46. Instead of opposed grooves 46 forholding the information card 48, other constructions, such as a pocket,could also be provided. It is also possible to attach the card directlyto the rear wall of the container using a magnet or Velcro arrangement.The slot 50 may be dimensioned to accommodate any size of paper.

The slot 50 formed by the grooves 46 can be used by pharmacists todisplay special notes on the information card 48 for the patient. Thenote would be printed on the information card upon printing of the label10. For example, the time the patient should take their medication canbe printed on the card 48. The card 48 can also include warningsregarding the medication.

The slot 50 can also be used to hold a magnifying lens 52 whichmagnifies the medication in the container 32 to make it more clearlyvisible to the patient (see FIG. 9). The magnifying lens 52 would bebeneficial to include with the container 32 for visually impaired andelderly patients or for patients who are frustrated by small typefaces.

In the preferred embodiment of the invention, the information card 48 isnot affixed to the container 32 but rather is removably received in theslot 50. This is possible because the information card 48 wouldtypically contain information supplemental to that on the label 10 sothat as long as the label 10 is still affixed to the container 32, themedication can be properly taken. However, when the information card isnot affixed to the container, warning stickers appearing on the back ofthe information card are also affixed to the planar surface of thecontainer so that, if the card is removed, the warning stickers remainvisible to the patient.

In another embodiment of the invention, the information card 48 isaffixed to the container. In this embodiment, the card 48 is affixed atone of its edges and the card is folded so that it rests flush with theplanar edge of the container. The patient unfolds the card 48 in orderto read its contents.

The containers 32 may be constructed in various sizes. Medicationcontainers are measured in drams and the number of drams reflects thecontent size of the bottle. At least three different size containers 32are envisioned, namely, a large size (90 dram, about 4 inches by 2.75inches), a medium size (30 dram, about 3.75 inches by 2 inches) and asmall size (10 dram, about 3 inches by 1.75 inches). The size of thecontainer 32 used by the pharmacist is selected according to the amountof medication prescribed.

In view of the different sizes of containers 32, the label 10 is alsoprovided with different sizes, one to fit each of the differentcontainers.

To produce the containers 32, an initial prototype mold of the containeris made. The initial mold has a single cavity into which plastic isinjected. A cavity is the space that forms the product by having plasticinjected into it. A container designer works with the prototype until itmeets with approval. Once a perfected prototype is complete, amulti-cavity mold can be made. The price of the mold varies according tothe size of the container and how many cavities there are. Once a moldis approved, production of the containers can proceed. The containers 30may be made of inexpensive recyclable plastic purchased from any numberof suppliers. A common type is polypropylene.

Another novel feature of the invention is the particular constructionand content of the information card 48 (see FIG. 8). The informationcard 48 is usable independent of the label 10 and the container 10,although preferably, the label 10, the container 32 and information card48 are used in combination with one another to provide optimalprotection against misuse of the prescribed medication.

In contrast to the prior art practice of providing information regardingthe prescribed medication printed on sheets of paper with long lines ofsmall type, the information card 48 in accordance with the invention isan easy-to-read, fold-out card that fits into the slot 50 formed by thegrooves 46 on the rear wall 36 of the container 32. In view of thedifferent sizes of containers 32, the card 48 will also be fabricated inthree different sizes, one to fit each container 32. The card 48 thushas a width of approximately twice the width of the slot 50 so that whenfolded in the middle, it will be securely retained in the slot 50. Thecard can also be folded more than two times in which case, its widthwill be equal to the width of the slot 50 times the number of foldedsections.

The information card 48 serves several purposes. The card provides thepatient with warnings and side effects about the medication. When apatient opens the card, he or she can read information and facts aboutthe particular drug. The warnings are placed on top of one anotherfacing outward and thus are the first thing the patient sees when he orshe turns the container 32 around. Even if the patient does not removethe information card 48 from the slot 50, he or she will be able to seethe warnings. These warnings are designed to replace the current warningstickers.

The information card 48 also provides a space for pharmacists to enteradditional notes that will help the patient comply with, e.g., dosageinstructions. As shown in FIG. 7, the information card 48 is retained ina fixed position relative to the container such that a portion 54 at theupper edge of the information card 48 extends beyond the cap 40 on whicha pharmacist or doctor may enter notes such as the time of day themedication should be taken (“BEDTIME”, “MORNING”, etc.). The informationcard 48 can then be positioned such that the portion 54 is visible whenthe container 32 is stored, e.g., in a medicine cabinet.

An additional card can be stapled to the bag in which the prescriptionis delivered and/or sold. This copy may be kept in the patient's walletin case of an emergency. Since the card is easily accessible, it can beused as a reference whenever necessary.

The information card 48 may be made formed of a waterproof material orsealed to be waterproof so it can be stored in a bathroom without riskof getting wet. Ideally, a patient collects an additional copy of eachcard and, by reviewing the card, is readily able to ascertain whatmedications he or she is taking.

The information card 48 can be used with containers having differentshapes than container 32. For example, information card 48 can be usedin connection with any container having a flat side, such as arectangular or square container. The information card 48 can also beused for cylindrical containers in which case, shoulders 44 can beformed at two peripheral locations around the container and theinformation card would be bent around a portion of the circumference ofthe container. Thus, the information card 48 can be used independent ofthe label 10 and container 32 described above.

Accordingly, a comprehensive labeling and packaging system forprescription medication is provided in accordance with the inventionwhich seeks to benefit consumers by delivering instructions, warningsand knowledge about medications in a clear and simple manner in order toavoid the incorrect use of medication. By creating a clear, wellthought-out system for labeling and packaging medications, an improveddispensing system will be created which will provide benefits to allparties involved. The medical industry will experience a decrease inmedical errors, health insurance companies will profit as a result oflower hospital bills, drug companies will face fewer lawsuits,pharmacists and doctors will be able to identify different drugs anddosages and consumer's experience with the health care industry will bemore satisfying

As to consumers, the system in accordance with the invention will likelyprovide the greatest benefit to prescription users over the age of 65.This group is at the highest risk of medication errors. There arecurrently more than 35 million Americans over the age of 65, andapproximately 6.3 million may not be able to correctly read thedirections that appear on their medicine labels. This problem is onlygoing to worsen as the baby boomer generation grows older.

The system in accordance with the invention is designed to be easilyreadable for people 65 and older. In view of the presence of pictogramsand the use of bold, clear typeface, among other features, illiterateand non-English-speaking citizens can also benefit from the invention.There are currently 40 million Americans who are functionally illiterate(reading at or below a fifth-grade level). Yet, like everyone, they needto understand how many times a day they should take their medication andwhat the side effects are.

Consumers will also benefit by the presence of distinguishing marks onthe label that may alert the pharmacist of the need to provideparticular, important information. For example, most pharmacists useautomatic label printing machines which generate labels. In accordancewith the invention, labels for some medications would be generated withmarking indicating a “HIGH ALERT” (in information area 18) or aparticular color in a specific region (the color red in information area28). Upon seeing one of these markings, the pharmacist is informed ofthe need to explain information about the product to the patient toavoid possible misuse.

In the practice of the invention, a label 10 is formed on a single sheetwith the information regarding the medication. Such a sheet is shown inFIG. 10 wherein two labels 10 are provided along with two informationareas and in FIG. 11 wherein the information about a particularprescription is printed.

While particular embodiments of the invention have been shown anddescribed, it will be obvious to those skilled in the art that changesand modifications may be made without departing from the invention inits broader aspects. For example, the invention is not limited toprescription medications for humans but can also be applied toover-the-counter medications and medications for animals. Therefore, theaim in the appended claims is to cover all such changes andmodifications as fall within the true spirit and scope of the invention.

1. A prescription container assembly, comprising: a receptacleconfigured to receive medication and including: a front wall; and a rearplanar wall forming a shoulder and including at least one medicationwarning identifier sticker applied to the rear planar wall; and whereinthe shoulder of the rear planar wall defines a slot; a cover engagingthe receptacle for sealing the receptacle; a label secured to thereceptacle to form a labeled receptacle; a color identifier disposed onthe labeled receptacle, the color identifier corresponding with at leastone of a medication parameter and a patient parameter; and a medicationinformation card containing information relating to the medication andbeing slidably and removably retained within the slot relative to therear planar wall of the receptacle, and wherein the medicationinformation card comprises a first portion including aprescription-related notation and wherein the medication informationcard and the slot are both sized and shaped so that upon full insertionof the medication information card within the slot, the first portion ofthe medication information card extends beyond an edge of the receptacleto make visible the prescription-related notation of the first portionof the medication information card beyond the edge of the receptacle,and wherein the at least one medication warning identifier stickerremains visible upon removal of the medication information card from theslot.
 2. The prescription container assembly of claim 1 wherein themedication information card comprises a foldable member including afolded position configured to be slidably removably retained within theslot.
 3. The prescription container assembly of claim 2, wherein thefoldable member is configured to be repeatedly folded into and unfoldedfrom the folded position.
 4. The prescription container assembly ofclaim 1 and further comprising a magnifying lens, wherein the slot issized and shaped to slidably removably retain both the magnifying lensand the medication information card.
 5. The prescription containerassembly of claim 1, in combination with medication contained in thereceptacle.
 6. The prescription container assembly of claim 1, whereinthe prescription-related notation includes indicia located on the firstportion of the medication information card, and the indicia is entirelylegible beyond the edge of the receptacle.
 7. The prescription containerassembly of claim 6, wherein the edge of the receptacle is an outermostedge of the receptacle.